First New Targeted Treatment for Drug-Resistant Tuberculosis Seeks Approval

Johnson and Johnson is seeking FDA approval for a drug for tuberculosis. If successful, it would be the first new drug type marketed for the illness in four decades.

Called bedaquiline, the drug targets multi-drug-resistant tuberculosis, from which 150,000 people die every year, and is the first drug specifically for it. Such a form of tuberculosis is resistant to two or more medications out of the four most common ones, and this form of tuberculosis is becoming increasingly common. Two mid-stage trials on the drug have been conducted on several hundred patients with some patients being studied for a year and a half. The next stage of testing will evaluate patients’ use of the drug over nine months as researchers seek to discover whether they can cut the length of treatment from 18 months to nine. Each patient will also take six other drugs that are standard for treatment of the disease; bedaquiline will be tested against placebo pills.

Dr. Wim Parys, head of infectious diseases for Johnson & Johnson’s Janssen Research and Development department, says that the company plans to seek approval in various other countries that are affected with the disease.

According to the World Health Organization, tuberculosis is the number-two killer of adults in terms of infectious diseases, second only to HIV/AIDS. Though it is comparatively rare in the United States, it kills around 1.4 million people each year across the globe. It is particularly deadly in developing countries, because current treatments take so long, and many patients stop taking their medication when they feel better – allowing their tuberculosis to become resistant to the drugs that have already been taken and makes it more difficult to pursue future treatments.

A third of people in the world carry the bacteria that lead to tuberculosis. In most, it lays dormant until a serious health problem or infection triggers it. Around 8.8 million people fell ill with tuberculosis in 2010 although it has been on the decline over the past decade.